Impact Instrumentation, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 27
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2430-2012 | Class III | Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufactur | March 30, 2012 |
| Z-2152-2012 | Class III | Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. In | March 19, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K133196 | IMPACT MODEL 323 ASPIRATOR | March 10, 2014 |
| K111473 | UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR | February 16, 2012 |
| K103318 | UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR | April 7, 2011 |
| K091238 | UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ | August 13, 2009 |
| K071526 | UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV | December 10, 2008 |
| K051476 | UNI-VENT MODEL 73X | October 28, 2005 |
| K032386 | UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) | March 26, 2004 |
| K022062 | IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 | May 6, 2003 |
| K951423 | ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT | April 18, 1995 |
| K941096 | ELECTRIC VACUM PUMP | January 5, 1995 |
| K931473 | IMPACT MODEL 753 | December 30, 1994 |
| K905697 | POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE | December 27, 1990 |
| K870861 | UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR | January 19, 1988 |
| K861272 | IMPACT MODELS 701, 702 AND 703 | May 20, 1986 |
| K851611 | IMPACT TURBO CATH | June 5, 1985 |
| K850671 | IMPACT 901 SERIES PORT-A-WALL | March 11, 1985 |
| K842050 | IMPACT MODEL 316 | August 3, 1984 |
| K841538 | IMPACT MODEL 308 | June 11, 1984 |
| K841537 | IMPACT MODEL 601 | May 31, 1984 |
| K820424 | IMPACT, MODEL 310 | March 12, 1982 |